MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION ARCHITECT FREE T4 (6 POINT CALIBRATOR ASSAY); RADIOIMMUNOASSAY, FREE THYROXINE

Catalog Number 07K65-77

Device Problem High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/02/2024

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Event Description

The customer observed falsely elevated architect free t4 results for one patient.The initial result was 32.17 pmol/l, recheck result was 17.66 pmol/l (reference range: 9.01-19.05 pmol/l).No impact to patient management was reported.

Manufacturer Narrative

Additional patient results added to the ticket on (b)(6) 2024.Initial ft4 test result was 21.11 pmol/l, recheck result was 16.38 pmol/l.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.H3 other text : device evaluation is in progress.

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Corrected data found in section d4 catalog # and lot #.

Manufacturer Narrative

Data and information provided by the customer were reviewed and support the complaint issue.The ticket search by lot indicates that the reagent lot shows elevated complaint activity, however, in-house performance testing was completed which indicates the product is performing as expected.Device history review did not identify any issues associated with the customer¿s observation.A review of ticket trending did not identify any related trend regarding commonalities for complaint lot number and issue.In-house performance testing was completed which indicates the product is performing as expected.Labeling review concludes that the issue is adequately addressed.Based on the investigation, no systemic issue or deficiency of the architect free t4 assay was identified.

• Brand Name: ARCHITECT FREE T4 (6 POINT CALIBRATOR ASSAY)
• Type of Device: RADIOIMMUNOASSAY, FREE THYROXINE
• Manufacturer (Section D): ABBOTT IRELAND DIAGNOSTICS DIVISION; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• Manufacturer (Section G): ABBOTT IRELAND DIAGNOSTICS DIVISION; lisnamuck; co. longford; longford N39E9 32; EI N39E932
• Manufacturer Contact: nicole jenne ; max-planck-ring 2; post market surveillance; wiesbaden 65205 ; GM 65205 ; 6122582960
• MDR Report Key: 18691431
• MDR Text Key: 335414021
• Report Number: 3005094123-2024-00058
• Device Sequence Number: 1
• Product Code: CEC
• UDI-Device Identifier: 00380740119805
• UDI-Public: 00380740119805
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K173122
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/06/2024
• Device Catalogue Number: 07K65-77
• Device Lot Number: 50481UD02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/02/2024
• Initial Date FDA Received: 02/12/2024
• Supplement Dates Manufacturer Received: 02/19/2024; 03/20/2024; 04/14/2024
• Supplement Dates FDA Received: 03/11/2024; 04/09/2024; 05/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/26/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC I2000SR INST, 03M74-02, ISR51280.; ARC I2000SR INST, 03M74-02, ISR51280.; ARC I2000SR INST, 03M74-02, ISR51280.; ARC I2000SR INST, 03M74-02, ISR51280.